Three Clinical Trials of Phenotropil Administration to Treat Cognitive Deficiencies

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Introduction

Below are 3 various clinical trials of Phenotropil (Phenylpiracetam) with patients suffering from different cognitive defficiencies.

Experience With Phenotropil Use In Patients With Initial Presentations Of Insufficient Cerebral Blood Supply

An open non-comparative study was performed by Selyanina N. V. and Shutov A. A. hosted by Perm Regional Clinical Hospital and Department of Neurology of Perm State Medical Academy to investigate Phenotropil efficiency in patients with initial presentations of insufficient cerebral blood supply (IPICBS).

Purpose of clinical trial: To evaluate Phenotropil efficiency resulted from the drug treatment courses in IPICBS patients.

Study design: 20 IPICBS patients (including 10 men and 10 women aged 40–50 years; average age – 46 years) were enrolled in the study. All the subjects received Phenotropil monotherapy [100 mg (1 tablet) daily]. The drug was administered in the morning for 30 days.

Results: Easy fatigability, hypomnesia, impaired concentration, hyperirritability and physical fatigue (n = 18), as well as lower mood (n = 16), sleep disturbances (n = 12), headache (n = 10), anxiety (n = 9) and dizziness episodes (n = 7) were observed in patients before treatment. These symptoms lasted within 3–11 months (average duration – 5.8 ± 1.3 months). Phenotropil treatment course termination was associated with decreased number of asthenic complaints, absence of dizziness episodes, substantial reduction of fatigability and physical fatigue, as well as mood improvement. Anxiety and irritability were reduced to a lesser extent in the setting of decreased intensity of headache. Moreover, patients mentioned “lucid head” sensation (n = 18), “energy surge” (n = 16), vivacity sensation (n = 13), weight loss by 2–5 kg (n = 6) and improved color sensitivity (n = 5). Asthenic parameters (MFI-20) reliably (р < 0.01) decreased to normal values; also, reliable reduction of decreased activity parameter was observed. According to Schulte Table Test results, number search became reliably (р < 0.01) faster after termination of Phenotropil treatment course. Depressive background analysis through Zung questionnaire showed similar presentation. Although “no depression” was mentioned in patients before and after treatment, composite score substantially reduced (34.1 ± 6.1 vs. 42.0 ± 8.5 scores) after the drug administration. Vegetative status analysis showed reliable (р < 0.05) decrease in values of subjective and objective assessment of vegetative disorders through a questionnaire and scheme (from 33.1 ± 10.4 and 40.6 ± 17.2 to 23.1 ± 1.3 and 28.8 ± 5.2 scores, respectively). After termination of treatment course quality of life reliably (p < 0.05) increased to 74.4 ± 15.0% in all the examined patients.

Tolerance: Several side effects (including sleep disturbances, excitation and anxiety) were mentioned in 2 women during the therapy. Drug withdrawal or decreased dosage were not required because all these events disappeared in 3–5 days after onset.

Conclusions: Therefore, Phenotropil administration (100 mg/day) provides reliable decrease in vegetative disorder intensity and asthenic values along with memory improvement in IPICBS patients with psychovegetative syndrome. Combined effect associated with reduced anxiety, low mood improvement and good tolerance reliably increases quality of patients’ life.

 

Experience With Phenotropil Use In Patients With Acute Brain Infarction

An open comparative trial was carried out by Bel’skaya G. N. et al. hosted by Neurovascular Department of Chelyabinsk Municipal Healthcare Institution No. 3 to investigate efficiency of Phenotropil (100 mg) and Piracetam to treat acute mild/moderate brain infarction.

Purpose of clinical trial: To evaluate cognitive functions associated with Phenotropil therapy, drug influence on neurological status symptoms and bioelectrical brain activity (before treatment, at Day 10 and Day 30 of Phenotropil therapy).

Study design: Brain infarction diagnosis was based on clinical neurological examination, laboratory testings of cerebrospinal fluid and blood, echoscopy, ocular fundus examination and brain CT scan. Exclusion criteria: impossibility of patient’s neuropsychological status evaluation due to speech disorders. Subjects were divided into 2 different groups. The main group included 30 subjects (49–65 years) who received oral dose of Phenotropil (100 mg, once a day) for 30 days. The second group (i. e., comparison group) included 12 subjects who received Piracetam tablets (1,600 mg/day; two-step administration at 8 a. m. and 2 p. m.) for 30 days.

Methods: Patients were investigated before treatment, at Day 10 and Day 30, respectively. The investigation included physical examination, neuropsychological testing through MMSE (Mini Mental State Examination) test, neurological disorder scoring as per original Gusev-Skvortsova scale (1991) and EEG.

Results: Perception and memory values reliably improved in both groups at Day 10. Also, mental alertness and counting values reliably ameliorated in Phenotropil patients. According to MMSE, perception, mental alertness, counting and memory values reliably improved in both groups at termination of 30-day treatment course. Also, speech functions substantially ameliorated in Phenotropil group. Significance point of pre- and post-treatment differences between these parameters in Phenotropil patients was higher than in Piracetam ones. According to original Gusev-Skvortsova scale, pre-treatment composite score was 37.1 ± 0.56 without intergroup differences. At Day 10 improved recovery of impaired functions was observed in Phenotropil patients, especially regarding ones with motor disturbances (composite score – 39.4 ± 0.21). This parameter was reliably (р < 0.01) lower in Piracetam patients (38.3 ± 0.18). At termination of acute phase of the disease, impaired function recovery efficiency whose evaluation was based on increased composite ischemic score was reliably (р < 0.01) higher in Phenotropil patients as compared with Piracetam ones [composite score (Day 30) – 44.2 ± 0.43 vs. 41.7 ± 0.28, respectively]. According to EEG changes, drug administration caused increased regularity and intensity of alpha activity, as well as improvement of EEG reactive parameters. That’s why, hyperventilation did not lead to substantial changes of brain bioelectrical activity.

Tolerance: Side effects were not detected.

Conclusions: As compared with Piracetam administration (1,600 mg/day), Phenotropil (100 mg/day) was associated with reliably (р < 0.01) better recovery of impaired functions in patients with acute mild/moderate brain infarction.

 

Phenotropil Use To Treat Asthenic-Depressive Syndromes Associated With Long-Term Effects Of Traumatic Brain Injuries

An open comparative clinical trial was carried out under the direction of Alyoshina N. V. hosted by Crisis Intervention Department of Saratov City Psychoneurological Health Centre to investigate Phenotropil monotherapy efficiency for management of asthenic-depressive syndromes associated with TBI long-term effects.

Study design: 26 patients with TBI long-term effects associated with asthenic-depressive, neurotic, hypochondriac and behavioral problems, lowered adaption and history of hospital treatment were examined. Patients were 37–43 years old; prevailing number of males was recorded. Disease duration: 7–10 years. All the patients were randomized to 2 groups (i. e., main and control ones) with the same age of subjects and disease duration. The main group (16 subjects) received oral dose of Phenotropil (100 mg/day) along with combined drug-free therapy (i. e., psychotherapy, exercise therapy, massage and physiotherapy). Apart from drug-free therapy, control group (10 subjects) received Piracetam (800 mg/day) and Vitamin B complex, as well as sedative and myorelaxing tranquilizers.

Methods: Intelligence, memory, rote memorization, fatigability, attention activity and visual memory were assessed during the study. Depression and anxiety levels were evaluated through Hamilton, Beck, Montgomery-Asberg and Zung rating scales. Anxiety syndrome intensity assessment was based on presence of anxiety experience, asthenization, vegetovascular manifestations, phobic disorders, lack of self-confidence, panic attacks, emotional instability, psychological dependability on other people, compulsive presentations, intrusive thoughts, negative anticipatory thinking episodes, irritability and somatic manifestations of anxiety. Cenesthopathic components of hypochondriac syndrome were evaluated according to subjective sensations, psychopathic-like manifestations and emotional-volitional impairments. Complete physical examination was carried out twice (before and after 30-day treatment).

Results: Significantly improved memorizing abilities associated with the therapy were observed in the main group (i. e., Phenotropil patients). Also, on the average, these subjects spent less time to choose a correct answer and this fact was considered in evaluation of changes in visual and rote memory. Phenotropil use resulted in decreased intensity of abnormal somatic-vegetative presentations (such as headache, dizziness and sweats), complete regression of anxiety, substantial increase in mood background which is approximate to smooth one without euphorization manifestations, reduced requirement of sleep without decrease in total sleep duration, weight stabilization and appetite recovery. After termination of Phenotropil administration course more critical attitude was mentioned in patients about their own state along with disappearance of daily mood variations and suicidal tendencies, as well as self-reproach regression and renewal of lost social relations.

Tolerance: No Phenotropil-induced side effects were mentioned during the study.

Conclusions: Thus, as compared with Piracetam, 30-day Phenotropil monotherapy (daily dose – 100 mg) showed higher therapeutic activity in patients with TBI long-term effects associated with asthenic-depressive and asthenic-neurotic syndromes. Phenotropil therapy enabled faster improvement of impaired higher mental functions than Piracetam administration.

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