Trial Outcomes & Findings for Ghrelin (OXE--103) for Acute Concussion Management (NCT NCT04558346)
NCT ID: NCT04558346
Last Updated: 2024-05-21
Results Overview
The primary goal is to describe the change in severity of symptoms in sub-acute concussion with treatment with OXE-103 using the Post Concussion Symptom Scale questionnaire during the intervention period at days 1 and 15 as well as during the post-treatment period at day 44. The Post Concussion Symptom Scale questionnaire consists of 23 common concussion symptoms which are assigned a ranking of severity on a scale from 0 (no symptom) to 6 (severe symptom). This tool is used to capture both severity of concussion symptoms as well as the number of symptoms. Data will be reported with the total values of all 23 subscale symptoms (total score = sum of all subscale symptom scores)--total can range from 0 to 138 with lower scores indicating lower symptom burden and higher scores a higher symptom burden (lower score = better outcome)
COMPLETED
PHASE2
23 participants
Days 1, 15, and 44
2024-05-21
Participant Flow
Participant milestones
| Measure |
Placebo/Standard of Care
Placebo (40ug/kg) will be self-administered twice daily for 14 days.
ONLY THE PART B (ACUTE) SUBJECTS WILL BE RANDOMIZED AND MAY RECEIVE PLACEBO. PART A (POST-ACUTE) SUBJECTS WILL ONLY RECEIVE STANDARD OF CARE (PHYSICAL THERAPY, SYMPTOMATIC TREATMENTS)
Placebo: 40ug/kg twice daily by self-injection
|
Ghrelin (OXE-103)
OXE-103 (40ug/kg) will be self-administered twice daily for 14 days.
PART A (POST-ACUTE) SUBJECTS WILL BE OFFERED EXPERIMENTAL TREATMENT WITHOUT RANDOMIZATION.
PART B (ACUTE) SUBJECTS WILL BE DOUBLE-BLIND RANDOMIZED TO EXPERIMENTAL OR PLACEBO TREATMENT.
Ghrelin (OXE-103): 40ug/kg twice daily by self-injection
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
15
|
|
Overall Study
COMPLETED
|
6
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Placebo/Standard of Care
Placebo (40ug/kg) will be self-administered twice daily for 14 days.
ONLY THE PART B (ACUTE) SUBJECTS WILL BE RANDOMIZED AND MAY RECEIVE PLACEBO. PART A (POST-ACUTE) SUBJECTS WILL ONLY RECEIVE STANDARD OF CARE (PHYSICAL THERAPY, SYMPTOMATIC TREATMENTS)
Placebo: 40ug/kg twice daily by self-injection
|
Ghrelin (OXE-103)
OXE-103 (40ug/kg) will be self-administered twice daily for 14 days.
PART A (POST-ACUTE) SUBJECTS WILL BE OFFERED EXPERIMENTAL TREATMENT WITHOUT RANDOMIZATION.
PART B (ACUTE) SUBJECTS WILL BE DOUBLE-BLIND RANDOMIZED TO EXPERIMENTAL OR PLACEBO TREATMENT.
Ghrelin (OXE-103): 40ug/kg twice daily by self-injection
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Ghrelin (OXE--103) for Acute Concussion Management
Baseline characteristics by cohort
| Measure |
Placebo/Standard of Care
n=8 Participants
Placebo (40ug/kg) will be self-administered twice daily for 14 days.
ONLY THE PART B (ACUTE) SUBJECTS WILL BE RANDOMIZED AND MAY RECEIVE PLACEBO. PART A (POST-ACUTE) SUBJECTS WILL ONLY RECEIVE STANDARD OF CARE (PHYSICAL THERAPY, SYMPTOMATIC TREATMENTS)
Placebo: 40ug/kg twice daily by self-injection
|
Ghrelin (OXE-103)
n=15 Participants
OXE-103 (40ug/kg) will be self-administered twice daily for 14 days.
PART A (POST-ACUTE) SUBJECTS WILL BE OFFERED EXPERIMENTAL TREATMENT WITHOUT RANDOMIZATION.
PART B (ACUTE) SUBJECTS WILL BE DOUBLE-BLIND RANDOMIZED TO EXPERIMENTAL OR PLACEBO TREATMENT.
Ghrelin (OXE-103): 40ug/kg twice daily by self-injection
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33 years
n=5 Participants
|
42 years
n=7 Participants
|
42 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
15 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1, 15, and 44The primary goal is to describe the change in severity of symptoms in sub-acute concussion with treatment with OXE-103 using the Post Concussion Symptom Scale questionnaire during the intervention period at days 1 and 15 as well as during the post-treatment period at day 44. The Post Concussion Symptom Scale questionnaire consists of 23 common concussion symptoms which are assigned a ranking of severity on a scale from 0 (no symptom) to 6 (severe symptom). This tool is used to capture both severity of concussion symptoms as well as the number of symptoms. Data will be reported with the total values of all 23 subscale symptoms (total score = sum of all subscale symptom scores)--total can range from 0 to 138 with lower scores indicating lower symptom burden and higher scores a higher symptom burden (lower score = better outcome)
Outcome measures
| Measure |
Standard of Care
n=6 Participants
STANDARD OF CARE (PHYSICAL THERAPY, SYMPTOMATIC TREATMENTS)
|
Ghrelin (OXE-103)
n=13 Participants
Ghrelin (OXE-103): 40ug/kg will be self-administered twice daily for 14 days.
|
|---|---|---|
|
Symptom Management - Post Concussion Symptom Scale
Day 1
|
44 score on a scale
Interval 28.0 to 71.0
|
71 score on a scale
Interval 47.0 to 73.0
|
|
Symptom Management - Post Concussion Symptom Scale
Day 15
|
39 score on a scale
Interval 28.0 to 68.0
|
51 score on a scale
Interval 24.0 to 69.0
|
|
Symptom Management - Post Concussion Symptom Scale
Day 44
|
45 score on a scale
Interval 6.0 to 67.0
|
20 score on a scale
Interval 7.0 to 43.0
|
|
Symptom Management - Post Concussion Symptom Scale
Change Day 15-Day 1
|
-1 score on a scale
Interval -14.0 to 4.0
|
-21 score on a scale
Interval -30.0 to -6.0
|
|
Symptom Management - Post Concussion Symptom Scale
Change Day 44-Day 1
|
-7 score on a scale
Interval -22.0 to 16.0
|
-34 score on a scale
Interval -44.0 to -24.0
|
SECONDARY outcome
Timeframe: Days 1, 15, and 44A secondary goal is to examine change in quality of life with treatment of sub-acute concussion using the Quality of Life after Brain Injury The QOLIBRI scores are reported on a 0-100 scale , where 0=worst possible quality of life and 100=best possible quality of life. Responses to the 'satisfaction' items (i.e. items on the Cognition, Self, Daily Life \& Autonomy, and Social Relationships scales) are on a 1-5 scale, 1= "not at all satisfied" and 5="very satisfied". Responses to the 'bothered' items (i.e. items on the Emotions and Physical Problems scales) are reverse scored to correspond with the satisfaction items, where 1="very bothered" and 5="not at all bothered". The responses on each scale are summed to give a total, and then divided by the number of responses to give a scale mean. The scale means have a maximum possible range of 1 to 5. In a similar manner the QOLIBRI Total score is calculated by summing all the responses, and then dividing by the actual number of responses.
Outcome measures
| Measure |
Standard of Care
n=6 Participants
STANDARD OF CARE (PHYSICAL THERAPY, SYMPTOMATIC TREATMENTS)
|
Ghrelin (OXE-103)
n=13 Participants
Ghrelin (OXE-103): 40ug/kg will be self-administered twice daily for 14 days.
|
|---|---|---|
|
Quality of Life - QOLIBRI-OS
Day 1
|
13 score on a scale
Interval 11.0 to 14.0
|
8 score on a scale
Interval 7.0 to 15.0
|
|
Quality of Life - QOLIBRI-OS
Day 15
|
11 score on a scale
Interval 7.0 to 17.0
|
17 score on a scale
Interval 8.0 to 19.0
|
|
Quality of Life - QOLIBRI-OS
Day 44
|
10 score on a scale
Interval 7.0 to 18.0
|
18 score on a scale
Interval 12.0 to 23.0
|
|
Quality of Life - QOLIBRI-OS
Change Day 15-Day 1
|
1 score on a scale
Interval -4.0 to 6.0
|
2 score on a scale
Interval 1.0 to 6.0
|
|
Quality of Life - QOLIBRI-OS
Change Day 44-Day 1
|
1 score on a scale
Interval -6.0 to 5.0
|
5 score on a scale
Interval 3.0 to 12.0
|
Adverse Events
Placebo/Standard of Care
Ghrelin (OXE-103)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo/Standard of Care
n=6 participants at risk
Placebo (40ug/kg) will be self-administered twice daily for 14 days.
ONLY THE PART B (ACUTE) SUBJECTS WILL BE RANDOMIZED AND MAY RECEIVE PLACEBO. PART A (POST-ACUTE) SUBJECTS WILL ONLY RECEIVE STANDARD OF CARE (PHYSICAL THERAPY, SYMPTOMATIC TREATMENTS)
Placebo: 40ug/kg twice daily by self-injection
|
Ghrelin (OXE-103)
n=15 participants at risk
OXE-103 (40ug/kg) will be self-administered twice daily for 14 days.
PART A (POST-ACUTE) SUBJECTS WILL BE OFFERED EXPERIMENTAL TREATMENT WITHOUT RANDOMIZATION.
PART B (ACUTE) SUBJECTS WILL BE DOUBLE-BLIND RANDOMIZED TO EXPERIMENTAL OR PLACEBO TREATMENT.
Ghrelin (OXE-103): 40ug/kg twice daily by self-injection
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • 44 days
|
20.0%
3/15 • 44 days
|
|
Skin and subcutaneous tissue disorders
Injection site pain
|
0.00%
0/6 • 44 days
|
33.3%
5/15 • 44 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • 44 days
|
26.7%
4/15 • 44 days
|
|
Skin and subcutaneous tissue disorders
Edema
|
0.00%
0/6 • 44 days
|
6.7%
1/15 • 44 days
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • 44 days
|
13.3%
2/15 • 44 days
|
|
Skin and subcutaneous tissue disorders
Bruising
|
0.00%
0/6 • 44 days
|
53.3%
8/15 • 44 days
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • 44 days
|
6.7%
1/15 • 44 days
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
0.00%
0/6 • 44 days
|
6.7%
1/15 • 44 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • 44 days
|
13.3%
2/15 • 44 days
|
|
General disorders
Fatigue
|
0.00%
0/6 • 44 days
|
26.7%
4/15 • 44 days
|
|
Infections and infestations
Infection
|
0.00%
0/6 • 44 days
|
6.7%
1/15 • 44 days
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/6 • 44 days
|
6.7%
1/15 • 44 days
|
|
Vascular disorders
Hot flash
|
0.00%
0/6 • 44 days
|
13.3%
2/15 • 44 days
|
|
Gastrointestinal disorders
Stomach Gurgling
|
0.00%
0/6 • 44 days
|
46.7%
7/15 • 44 days
|
|
General disorders
Insomnia
|
0.00%
0/6 • 44 days
|
6.7%
1/15 • 44 days
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/6 • 44 days
|
53.3%
8/15 • 44 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • 44 days
|
13.3%
2/15 • 44 days
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/6 • 44 days
|
6.7%
1/15 • 44 days
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • 44 days
|
6.7%
1/15 • 44 days
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • 44 days
|
13.3%
2/15 • 44 days
|
|
General disorders
Vivid dreams
|
0.00%
0/6 • 44 days
|
6.7%
1/15 • 44 days
|
|
Metabolism and nutrition disorders
Increased thirst
|
0.00%
0/6 • 44 days
|
13.3%
2/15 • 44 days
|
|
Investigations
Increased ALT (Grade 2)
|
0.00%
0/6 • 44 days
|
6.7%
1/15 • 44 days
|
|
Investigations
Increased AST
|
0.00%
0/6 • 44 days
|
6.7%
1/15 • 44 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place