Trial Outcomes & Findings for Treatment of Patients Suffering From Nervous Restlessness With PASCOFLAIR® (NCT NCT02651922)

NCT ID: NCT02651922

Last Updated: 2024-07-30

Results Overview

Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

• Recruitment status: COMPLETED
• Target enrollment: 154 participants
• Primary outcome timeframe: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
• Results posted on: 2024-07-30

Participant Flow

Participant milestones

Measure	PASCOFLAIR Group (Verum) Patients who were treated with PASCOFLAIR
Overall Study STARTED	156
Overall Study COMPLETED	154
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	PASCOFLAIR Group (Verum) Patients who were treated with PASCOFLAIR
Overall Study due to exclusion criteria	2

Baseline Characteristics

Treatment of Patients Suffering From Nervous Restlessness With PASCOFLAIR®

Baseline characteristics by cohort

Measure	PASCOFLAIR Group (Verum) n=154 Participants Patients who were treated with PASCOFLAIR
Age, Customized <=18 years	1 participants n=5 Participants
Age, Customized Between 18 and 65 years	128 participants n=5 Participants
Age, Customized >=65 years	23 participants n=5 Participants
Age, Customized missing data	2 participants n=5 Participants
Age, Continuous	47.9 years STANDARD_DEVIATION 17.1 • n=5 Participants
Sex/Gender, Customized Female	115 participants n=5 Participants
Sex/Gender, Customized Male	38 participants n=5 Participants
Sex/Gender, Customized missing data	1 participants n=5 Participants
Region of Enrollment Germany	154 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)

Population: If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent. Only 146 patients showed this symptom.

Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

Outcome measures

Measure	PASCOFLAIR Group (Verum) n=146 Participants Patients who were treated with PASCOFLAIR
Change of Symptom Inner Restlessness (Pre - Post) improved	137 participants
Change of Symptom Inner Restlessness (Pre - Post) unchanged	3 participants
Change of Symptom Inner Restlessness (Pre - Post) detoriated	6 participants

SECONDARY outcome

Timeframe: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)

Population: If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent. Only 146 patients showed this symptom.

Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

Outcome measures

Measure	PASCOFLAIR Group (Verum) n=146 Participants Patients who were treated with PASCOFLAIR
Change of Symptom Sleep Disturbance (Pre - Post) improved	131 participants
Change of Symptom Sleep Disturbance (Pre - Post) unchanged	8 participants
Change of Symptom Sleep Disturbance (Pre - Post) deteriorated	7 participants

SECONDARY outcome

Timeframe: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)

Population: If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent. Only 145 patients showed this symptom.

Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

Outcome measures

Measure	PASCOFLAIR Group (Verum) n=145 Participants Patients who were treated with PASCOFLAIR
Change of Symptom Exhaustion (Pre - Post) improved	130 participants
Change of Symptom Exhaustion (Pre - Post) unchanged	7 participants
Change of Symptom Exhaustion (Pre - Post) detoriorated	8 participants

SECONDARY outcome

Timeframe: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)

Population: If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent. Only 133 patients showed this symptom.

Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

Outcome measures

Measure	PASCOFLAIR Group (Verum) n=133 Participants Patients who were treated with PASCOFLAIR
Change of Symptom Fear (Pre - Post) improved	121 participants
Change of Symptom Fear (Pre - Post) unchanged	6 participants
Change of Symptom Fear (Pre - Post) detoriorated	10 participants

SECONDARY outcome

Timeframe: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)

Population: If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent. Only 142 patients showed this symptom.

Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

Outcome measures

Measure	PASCOFLAIR Group (Verum) n=142 Participants Patients who were treated with PASCOFLAIR
Change of Symptom Lack of Concentration (Pre - Post) improved	123 participants
Change of Symptom Lack of Concentration (Pre - Post) unchanged	11 participants
Change of Symptom Lack of Concentration (Pre - Post) detoriorated	8 participants

SECONDARY outcome

Timeframe: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline )

Population: If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent. Only 121 patients showed this symptom.

Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

Outcome measures

Measure	PASCOFLAIR Group (Verum) n=121 Participants Patients who were treated with PASCOFLAIR
Change of Symptom Transpiration (Pre - Post) improved	106 participants
Change of Symptom Transpiration (Pre - Post) unchanged	9 participants
Change of Symptom Transpiration (Pre - Post) detoriorated	6 participants

SECONDARY outcome

Timeframe: Change from Baseline (before treatment; week 0) to last visit (end of observation-approx. 12 weeks after baseline)

Population: If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent. Only 92 patients showed this symptom.

Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

Outcome measures

Measure	PASCOFLAIR Group (Verum) n=92 Participants Patients who were treated with PASCOFLAIR
Change of Symptom Nausea (Pre - Post) improved	79 participants
Change of Symptom Nausea (Pre - Post) unchnaged	7 participants
Change of Symptom Nausea (Pre - Post) detoriorated	6 participants

SECONDARY outcome

Timeframe: Change from Baseline (before treatment; week 0) to last visit (end of observation - approx. 12 weeks after baseline)

Population: If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent. Only 108 patients showed this symptom.

Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

Outcome measures

Measure	PASCOFLAIR Group (Verum) n=108 Participants Patients who were treated with PASCOFLAIR
Change of Symptom Trembling (Pre - Post) improved	91 participants
Change of Symptom Trembling (Pre - Post) unchanged	8 participants
Change of Symptom Trembling (Pre - Post) deterioreated	9 participants

SECONDARY outcome

Timeframe: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)

Population: If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent. Only 130 patients showed this symptom.

Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

Outcome measures

Measure	PASCOFLAIR Group (Verum) n=130 Participants Patients who were treated with PASCOFLAIR
Change of Symptom Palpation (Pre - Post) improved	117 participants
Change of Symptom Palpation (Pre - Post) unchanged	9 participants
Change of Symptom Palpation (Pre - Post) deteriorated	4 participants

SECONDARY outcome

Timeframe: Change from visit 2 (approx. 4 weeks after baseline) to last visit (end of observation- approx. 12 weeks after baseline)

Population: For patient with less than 75% items answered the BDEPQ-Score was not calculated. For only 132 patients Score was calculated.

The Benzodiazepine Dependence Questionnaire (BDEPQ) is a 30 item self report questionnaire designed to measure dependence on benzodiazepine tranquilisers, sedatives and hypnotics. Items cover all aspects of the dependence syndrome with the exception of withdrawal symptoms. Each item is rated on a four point likert scale referring to experiences in the last month.

BDEPQ score ranges from 0 (no dependence) to 85 (most severe dependence).

Outcome measures

Measure	PASCOFLAIR Group (Verum) n=132 Participants Patients who were treated with PASCOFLAIR
Change of BDEPQ (Benzodiazepine Dependence Questionnaire) improved	91 participants
Change of BDEPQ (Benzodiazepine Dependence Questionnaire) unchanged	13 participants
Change of BDEPQ (Benzodiazepine Dependence Questionnaire) deteriorated	28 participants

SECONDARY outcome

Timeframe: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)

RS-13 is a 13 items self Report questionnaire measure the resilience, which applies a reliance scale ranging from 13 (lowest stress resistance) to 91 (highest stress resistance).

Outcome measures

Measure	PASCOFLAIR Group (Verum) n=132 Participants Patients who were treated with PASCOFLAIR
Change of RS-13 (Resilience Questionnaire) (Pre - Post) improved	115 participants
Change of RS-13 (Resilience Questionnaire) (Pre - Post) unchanged	3 participants
Change of RS-13 (Resilience Questionnaire) (Pre - Post) deteriorated	14 participants

SECONDARY outcome

Timeframe: Change from Baseline (before treatment) to last visit (end of observation- approx. 12 weeks after baseline)

EQ-5D™ is a standardised instrument for use as a measure of health Outcome The EQ-5D assesses five aspects of QoL: mobility, self-care, usual activity, pain/discomfort and anxiety/depression. An EQ-5D profile score of 0 points represents the worst QoL (death), while 1 point stands for full health. Data analysis was performed according to the EuroQol manual. The EQ-VAS ranges from 0 (worst QoL) to 100 (best QoL).

Outcome measures

Measure	PASCOFLAIR Group (Verum) n=133 Participants Patients who were treated with PASCOFLAIR
Change in EQ-5D (Health Questionnaire) Scores (Pre - Post) improved	104 participants
Change in EQ-5D (Health Questionnaire) Scores (Pre - Post) unchanged	22 participants
Change in EQ-5D (Health Questionnaire) Scores (Pre - Post) deterioreated	7 participants

SECONDARY outcome

Timeframe: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)

VAS values (Quality of Life) range from 0 (very poor) to 100 (best possible state).

Outcome measures

Measure	PASCOFLAIR Group (Verum) n=134 Participants Patients who were treated with PASCOFLAIR
Change of EQ-5D VAS Scores (Pre - Post) improved	119 participants
Change of EQ-5D VAS Scores (Pre - Post) unchanged	5 participants
Change of EQ-5D VAS Scores (Pre - Post) deteriorated	11 participants

SECONDARY outcome

Timeframe: Evaluation of Tolerability on visit 3 (appr. 12 weeks after baseline)

Assessment of tolerability using a 5 point scale (very good, good, satisfactory, bad, very bad)

Outcome measures

Measure	PASCOFLAIR Group (Verum) n=148 Participants Patients who were treated with PASCOFLAIR
Tolerability Assess Using a 5 Point Scale very good	109 participants
Tolerability Assess Using a 5 Point Scale good	35 participants
Tolerability Assess Using a 5 Point Scale satisfactory	2 participants
Tolerability Assess Using a 5 Point Scale bad	1 participants
Tolerability Assess Using a 5 Point Scale very bad	1 participants

Adverse Events

PASCOFLAIR Group (Verum)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	PASCOFLAIR Group (Verum) n=154 participants at risk Patients who were treated with PASCOFLAIR
Gastrointestinal disorders Fatigue	1.9% 3/154 • Number of events 3 • The observational period was from September 2014 till June 2015. Per Patient were adrs collected for the treatment period (12 weeks).
Nervous system disorders Numbness in limbs	0.65% 1/154 • Number of events 1 • The observational period was from September 2014 till June 2015. Per Patient were adrs collected for the treatment period (12 weeks).

Additional Information

Dr. Inga Trompetter and Jennifer Lebert

PASCOE Pharmazeutische Präparate GmbH

Phone: 0049-(0)641-7960-955

Email: Jennifer.lebert@pascoe.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place