Trial Outcomes & Findings for A Pilot Study Of Riluzole In Patients With Post Traumatic Stress Disorder (PTSD) (NCT NCT02019940)

NCT ID: NCT02019940

Last Updated: 2020-04-01

Results Overview

The CAPS is a standardized clinician-rated instrument to assess the presence and severity of PTSD symptoms. The scores range from 0 (minimum) to 80 (mazimum). Higher scores reflect worse symptoms.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 18 participants
• Primary outcome timeframe: Change from baseline to 12 weeks
• Results posted on: 2020-04-01

Participant Flow

Participant milestones

Measure	Riluzole Open Label Subjects diagnosed with PTSD will receive riluzole, 50 mg taken orally twice daily (BID) for 12 weeks
Overall Study STARTED	18
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study Of Riluzole In Patients With Post Traumatic Stress Disorder (PTSD)

Baseline characteristics by cohort

Measure	Riluzole Open Label n=9 Participants Subjects diagnosed with PTSD will receive riluzole, 50 mg taken orally twice daily (BID) for 12 weeks
Age, Continuous	44.7 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to 12 weeks

Population: 18 participants started the study and 9 participants were randomized into the single arm of the study. However, only 8 participants completed the treatment. Since there was some treatment data collected on the 9th participant, he/she was included in the analysis.

The CAPS is a standardized clinician-rated instrument to assess the presence and severity of PTSD symptoms. The scores range from 0 (minimum) to 80 (mazimum). Higher scores reflect worse symptoms.

Outcome measures

Measure	Riluzole Open Label n=9 Participants Subjects diagnosed with PTSD will receive riluzole, 50 mg taken orally twice daily (BID) for 12 weeks
Change in Clinician Administered PTSD Scale (CAPS)	-20.67 units on a scale Standard Deviation 21.16

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

Adverse Events

Riluzole Open Label

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Riluzole Open Label n=9 participants at risk Subjects diagnosed with PTSD will receive riluzole, 50 mg taken orally twice daily (BID) for 12 weeks
General disorders Abdominal Pain	11.1% 1/9 • 8 weeks The reporting of the adverse events reflects that one participant could have experienced more than one adverse event. For example, one participant experienced both dry mouth and lightheadedness. Similarly, three participants could have experienced chest pain. Thus, it may seem like the number of participants that experienced various adverse events does not match up to the number of participants in the participant flow. We analyzed 9 participants total and recorded their AEs in this section.
General disorders Dry mouth	22.2% 2/9 • 8 weeks The reporting of the adverse events reflects that one participant could have experienced more than one adverse event. For example, one participant experienced both dry mouth and lightheadedness. Similarly, three participants could have experienced chest pain. Thus, it may seem like the number of participants that experienced various adverse events does not match up to the number of participants in the participant flow. We analyzed 9 participants total and recorded their AEs in this section.
General disorders Altered Taste Sensation	11.1% 1/9 • 8 weeks The reporting of the adverse events reflects that one participant could have experienced more than one adverse event. For example, one participant experienced both dry mouth and lightheadedness. Similarly, three participants could have experienced chest pain. Thus, it may seem like the number of participants that experienced various adverse events does not match up to the number of participants in the participant flow. We analyzed 9 participants total and recorded their AEs in this section.
General disorders Light headedness	22.2% 2/9 • 8 weeks The reporting of the adverse events reflects that one participant could have experienced more than one adverse event. For example, one participant experienced both dry mouth and lightheadedness. Similarly, three participants could have experienced chest pain. Thus, it may seem like the number of participants that experienced various adverse events does not match up to the number of participants in the participant flow. We analyzed 9 participants total and recorded their AEs in this section.
General disorders Headache	22.2% 2/9 • 8 weeks The reporting of the adverse events reflects that one participant could have experienced more than one adverse event. For example, one participant experienced both dry mouth and lightheadedness. Similarly, three participants could have experienced chest pain. Thus, it may seem like the number of participants that experienced various adverse events does not match up to the number of participants in the participant flow. We analyzed 9 participants total and recorded their AEs in this section.
General disorders Rhinitis, congestion, sinus pressure, postnasal drip	11.1% 1/9 • 8 weeks The reporting of the adverse events reflects that one participant could have experienced more than one adverse event. For example, one participant experienced both dry mouth and lightheadedness. Similarly, three participants could have experienced chest pain. Thus, it may seem like the number of participants that experienced various adverse events does not match up to the number of participants in the participant flow. We analyzed 9 participants total and recorded their AEs in this section.
General disorders bruxism	11.1% 1/9 • 8 weeks The reporting of the adverse events reflects that one participant could have experienced more than one adverse event. For example, one participant experienced both dry mouth and lightheadedness. Similarly, three participants could have experienced chest pain. Thus, it may seem like the number of participants that experienced various adverse events does not match up to the number of participants in the participant flow. We analyzed 9 participants total and recorded their AEs in this section.
General disorders fatigue	33.3% 3/9 • 8 weeks The reporting of the adverse events reflects that one participant could have experienced more than one adverse event. For example, one participant experienced both dry mouth and lightheadedness. Similarly, three participants could have experienced chest pain. Thus, it may seem like the number of participants that experienced various adverse events does not match up to the number of participants in the participant flow. We analyzed 9 participants total and recorded their AEs in this section.
General disorders chest pain	33.3% 3/9 • 8 weeks The reporting of the adverse events reflects that one participant could have experienced more than one adverse event. For example, one participant experienced both dry mouth and lightheadedness. Similarly, three participants could have experienced chest pain. Thus, it may seem like the number of participants that experienced various adverse events does not match up to the number of participants in the participant flow. We analyzed 9 participants total and recorded their AEs in this section.
General disorders dry cough	11.1% 1/9 • 8 weeks The reporting of the adverse events reflects that one participant could have experienced more than one adverse event. For example, one participant experienced both dry mouth and lightheadedness. Similarly, three participants could have experienced chest pain. Thus, it may seem like the number of participants that experienced various adverse events does not match up to the number of participants in the participant flow. We analyzed 9 participants total and recorded their AEs in this section.
General disorders urinary urgency	11.1% 1/9 • 8 weeks The reporting of the adverse events reflects that one participant could have experienced more than one adverse event. For example, one participant experienced both dry mouth and lightheadedness. Similarly, three participants could have experienced chest pain. Thus, it may seem like the number of participants that experienced various adverse events does not match up to the number of participants in the participant flow. We analyzed 9 participants total and recorded their AEs in this section.
General disorders edema	22.2% 2/9 • 8 weeks The reporting of the adverse events reflects that one participant could have experienced more than one adverse event. For example, one participant experienced both dry mouth and lightheadedness. Similarly, three participants could have experienced chest pain. Thus, it may seem like the number of participants that experienced various adverse events does not match up to the number of participants in the participant flow. We analyzed 9 participants total and recorded their AEs in this section.

Additional Information

Chadi Abdallah

Yale School of Medicine

Phone: 347-987-0717

Email: chadi.abdallah@yale.edu

Results disclosure agreements

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